MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ BI VIO 5IN2 USP3-0 D/A PS-2; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP2B100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty on (b)(6) 2026 and a barbed suture was used.During dermal closure, the needle tip broke.The hospital determined that based on x-ray results, no foreign matter left in the patient.The wound was re-closed with a different suture.After that, no additional treatment is planned.The patient¿s condition is no particular differences comparable to other cases.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: lot number? 10btur.Unknown if this is the correct lot number.After placing 2-3 stitches, discomfort was felt around the fourth stitch, so the doctor checked, it was found that the needle tip was missing.It could not be found by x-ray.The procedure was then completed using 3-0 pds plus for suturing.The hospital determined that based on x-ray results, no foreign matter left in the patient.The wound was re-closed with 3-0 pds, and after that no additional treatment is planned.The patient¿s condition is no particular differences comparable to other cases.What is the lot number? 10btur.When did the needle break (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify - during dermis suturing.Did the needle fall into the patient? if yes, was the needle piece removed from the patient during the same procedure? unk.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.The device has been received and will be shipped.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/3/2026.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 component code: g07002 no device problem found.H6 component code: c22 - photo analysis.Additional information: d9, h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.One empty labeled winding former and two needle-suture pieces were received for analysis.Product code sxpp2b100; this code is double armed.During visual inspection of the two returned needles, one was found to have an improperly formed tip resulting in a missing point; the other showed no damage and had an intact point.Additionally, six photographs were provided, clearly displaying the damaged tip, which is consistent with the condition of the received sample.Based on the information currently available, a missing point was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: SFX SPI PDS+ BI VIO 5IN2 USP3-0 D/A PS-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24536147
• Report Number: 2210968-2026-02350
• Device Sequence Number: 13346669
• Product Code: NEW
• UDI-Device Identifier: 10705031465190
• UDI-Public: (01)10705031465190(17)270930(10)10BTUR
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K192144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SXPP2B100
• Device Lot Number: 10BTUR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown